Characterizing Uveal Melanoma through Tissue Analysis
Morphological, Genetic and Tumour Microenvironment Characterisation in Uveal Melanoma and Impact on the Development of Metastasis and Mortality.
This study looks at tissue samples from patients with uveal melanoma to see if certain characteristics can help predict how the disease will progress and respond to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05889481 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the morphological and genetic characteristics of uveal melanoma to identify molecular prognostic factors associated with disease severity, tumor progression, and treatment response. It utilizes archived formalin-fixed, paraffin-embedded tissue samples from patients who have undergone surgical procedures. The study involves immunohistochemical and genetic analyses performed on these samples to gather insights into the tumor microenvironment and its implications for patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with a clinical and histological diagnosis of uveal melanoma and sufficient archived tissue samples.
Not a fit: Patients under 18 years old or those without adequate clinical data or follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic assessments and personalized treatment strategies for patients with uveal melanoma.
How similar studies have performed: Other studies have shown success in characterizing tumors through similar morphological and genetic analyses, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older; 2. Clinical and histological diagnosis of uveal melanoma; 3. Ability to obtain formalin-fixed, paraffin-embedded tissue (FFPE). 4. Availability of genetic analysis results from tumour tissue obtained by enucleation or fine-needle biopsy. 5. Follow-up of at least 5 years from enucleation or fine-needle biopsy. 6. Written informed consent to use the data for research purposes. Exclusion Criteria: 1. Age \< 18 years; 2. Lack of sufficient clinical data on selected patients. 3. Follow-up of less than 5 years. 4. Refusal to give informed consent to data processing for research purposes.
Where this trial is running
Rome
- Monica Maria Pagliara - Oncologia Oculare — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Monica Maria Pagliara, MD,PhD
- Email: oncologiaoculare@policlinicogemelli.it
- Phone: 0630154528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.